CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria

Summary

The purpose of this study is to evaluate the effects of CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) compared to Meropenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis caused by β-lactamase producing gram-negative bacteria

Conditions

• Urinary Tract Infection Complicated
• Acute Pyelonephritis

Interventions

DRUG

CSE-1034 (Ceftriaxone + Sulbactam + EDTA)

CSE-1034 (Ceftriaxone + Sulbactam + EDTA) was Experimental in this study and is a combination of Ceftriaxone 1000mg, Sulbactam 500mg and EDTA 37mg available as dry powder for reconstitution. Patients were given either CSE-1034 or placebo through IV route four times daily, strictly adhering to the time interval. Time of the first dose (Drug) was considered 0th hr, the second dose (Placebo) was given at 8th hour from first dose, third dose (Drug) at 12th hour from first dose and the fourth dose (Placebo) at 16th hour from first dose. The infusion was initiated within ± 30 min of schedule time.

DRUG

Meropenem

Meropenem was the Comparator in the study. It was also available as dry powder for reconstitution and contained active ingredient Meropenem 1000mg.Patients were given either Meropenem or placebo through IV route four times daily, strictly adhering to the time interval. Time of the first dose (Drug) was considered 0th hr, the second dose (Drug) was given at 8th hour from first dose, third dose (Placebo) at 12th hour from first dose and the fourth dose (Drug) at 16th hour from first dose. The infusion was initiated within ± 30 min of schedule time.

Sponsors & Collaborators

• Venus Remedies Limited

  lead INDUSTRY

Principal Investigators

• Rajeev Sood · PGIMER Dr. RML Hospital, Baba Kharak Singh Marg, Connaught Place, New Delhi- 110001, India

• Kim Mammen · Christian Medical College & Hospital, Ludhiana, Punjab-141008, India

• R.P Agrawal · S.P. Medical College, Bikaner- 334003, Rajasthan, India

• Manjunath M · Sapthagiri Institute of Medical Sciences and Research Center, #15, Chikkasandra, Hesaragatta Main Road, Bangalore-560 090, Karnataka, India

• Pratibha Phadke · Deenanath Mangeshkar Hospital and Research Centre, Erandwane, Pune - 411004

• Sudhir Chadha · Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi- 110060, India

• A.K. Deb · Sudbhawana Hospital, B 31/8023-B, Bhogabir, Lanka, Varanasi- 221005, India

• Dharamraj Maurya · M.V. Hospital and Research Centre, 314/30, Mirza Mandi, Chowk, Lucknow- 226003, India

• Deepak Dewan · Ajanta Hospital & Research Centre, 765, ABC Complex, Kanpur Road, Alambagh, Lucknow-Uttar Pradesh, 226005, India.

• Shalini Srivastava · Om Surgical Centre and Maternity Home, SA 17/3, P-4, Sri Krishna Nagar, Paharia, Ghazipur Road, Varanasi- 221007, India

• Ram Murti Singh · Trimurti Hospital, Gilat Bazaar, Varanasi- 221002, India

• Rahul Janak Sinha · King George's Medical University (KGMU), Lucknow-226003, India

• Madhav Prabhu · KLES, Dr Prabhakar Kore Hospital and Medical Centre, Nehru Nagar, Belagavi- 590010, Belgaum, Karnataka, India

• Mohd. Shameem · J. N. Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India

• Prem Nath Dogra · All India Institute of Medical Science, Ansari Nagar, New Delhi- 110029, India

• Ravimohan S Mavuduru · P. G. I. M. E. R., Sector 12, Chandigarh-160012, India

• Parvaiz Koul · SKIMS, Srinagar, Jammu & Kashmir- 190011, India

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-11

Primary Completion

2017-05-08

Completion

2017-05-08

Countries

• India

Study Locations